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Sorafenib for the treatment of unresectable hepatocellular carcinoma in HIV-positive patients

Berretta, Massimilianoa; Di Benedetto, Fabriziod; Dal Maso, Luiginob; Cacopardo, Brunof; Nasti, Guglielmog; Facchini, Gaetanog; Bearz, Alessandraa; Spina, Michelea; Garlassi, Elisae; De Re, Vallic; Fiorica, Francescoh; Lleshi, Arbena; Tirelli, Umbertoa

doi: 10.1097/CAD.0b013e32835c032f

Few data are available on the safety and efficacy of sorafenib in HIV-infected patients with unresectable hepatocellular carcinoma (HIV-u-HCC) and concomitant highly active antiretroviral therapy (HAART). Between July 2007 and October 2010, 27 consecutive HIV-u-HCC patients were treated with sorafenib and concomitant HAART within the Gruppo Italiano Cooperativo AIDS e Tumori (GICAT). Three patients achieved a partial response, 12 achieved a stable disease, and 12 showed progression. The median time to progression and overall survival was 5.1 (range 0.5–13.3) and 12.8 (range 1.1–23.5) months, respectively. Grades 3–4 toxicities included diarrhea (four patients, 14.8%), hypertension (three patients, 11%), and hand-and-foot skin reaction (four patients, 14.9%). Most drug-related side effects were low grade and manageable. This retrospective study shows favorable survival data among HIV-u-HCC patients treated with sorafenib together with a reasonable safety profile.

aDepartment of Medical Oncology

bScientific Directorate, Epidemiology and Biostatistics Unit

cDepartment of Molecular Oncology and Translational Medicine, Clinical and Experimental Pharmacology Unit, National Cancer Institute – IRCCS, Aviano (PN)

dDepartment of General Surgery and Specialty Surgery, Liver and Multivisceral Transplant Center

eDepartment of Medicine and Medical Specialties, Unit of Infectious Diseases, University of Modena and Reggio Emilia, Modena

fDepartment of Internal Medicine and Medical Specialties, Unit of Infectious Diseases, ‘Garibaldi-Nesima’ Hospital, University of Catania, Catania

gDepartment of Medical Oncology, Division of Medical Oncology B, National Cancer Institute ‘Pascale’, Naples

hDepartment of Radiotherapy, Arcispedale S. Anna Hospital, Ferrara, Italy

Correspondence to Massimiliano Berretta, MD, PhD, Department of Medical Oncology, National Cancer Institute – IRCCS, Via F. Gallini 2, 33081 Aviano (PN), Italy Tel: +39 0434 659724; fax: +39 0434 659531; e-mail:

Received September 15, 2012

Accepted October 29, 2012

© 2013 Lippincott Williams & Wilkins, Inc.